Protech Leaded Eyewear
Form 483 issued March 10, 2025 · Lake Park, Florida
- Inspection
- Mar 4 – Mar 10, 2025
- Investigator
- David M. Wilkinson
- Observations
- 3
- Pages
- 28
- FEI number
- 1000488948
In short: On March 10, 2025, FDA issued a Form 483 with 3 observations to Protech Leaded Eyewear in Lake Park, Florida (FEI 1000488948) after an inspection that ran Mar 4 – Mar 10, 2025. The investigator was David M. Wilkinson. Most observations concern design controls and management controls.
At a glance
Design controls and management controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 0221 CFR 820.2221 CFR 820
Procedures for quality audits…
- 03
Complaint files are not…
This inspection in context
David M. Wilkinson
7 documents · 2018–2025
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmProtech Leaded Eyewear history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Protech Leaded Eyewear?
FDA listed 3 observations on this Form 483, mostly about design controls, management controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Protech Leaded Eyewear?
David M. Wilkinson is named on this Form 483, for the inspection of Mar 4 – Mar 10, 2025. Each investigator has a profile showing what they cite most.
When was Protech Leaded Eyewear inspected by FDA?
The inspection ran Mar 4 – Mar 10, 2025, and the Form 483 is dated March 10, 2025.
How do I get the full Form 483 for Protech Leaded Eyewear?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.